Some physicians are concerned that provisions in the act could actually harm the drug and device marketplace by encouraging the FDA to emphasize speed over science.

What to Look for in a Disability Policy

Another component of the 21st Century Cures Act is to build on the U.S. Food and Drug Administration’s (FDA) ongoing efforts to advance medical product innovation and ensure that patients get access to treatments as quickly as possible, with continued assurance from high-quality evidence that they are safe and effective, stated Robert M. Califf, MD, commissioner of the FDA.

“The FDA’s approval process for pharmacologic agents and devices is designed to protect patients and ensure quality and safety,” said Joseph E. Kerschner, MD, dean of the School of Medicine and executive vice president of Medical College of Wisconsin in Milwaukee, and chair-elect of the Council of Deans for the Association of American Medical Colleges, based in Washington, D.C. “However, the process is expensive and time consuming, which can delay the ability for patients to access cutting-edge therapies. The Cures Act admirably attempts to continue to safeguard FDA approvals appropriately, but will also look at ways that enhance efficacy and efficiency in bringing new therapies to market without lessening patient safety. The act may provide some beneficial changes to regulations, which will help streamline processes and deliver new technologies more effectively.”

But Michael S. Sinha, MD, JD, MPH, a postdoctoral fellow in the Program On Regulation, Therapeutics, And Law (PORTAL) at Boston’s Brigham and Women’s Hospital/Harvard Medical School, and some of his colleagues are concerned that some of the act’s provisions could actually harm the drug and device marketplace by encouraging the FDA to emphasize speed over science and rely on less rigorous data for approving new products and indications.

While the FDA was slow to give approvals 30 years ago, that is not true today, Dr. Sinha said. Currently, the FDA is among the fastest drug regulatory agencies in the world. A Yale study showed that between 2011 and 2015, FDA approvals were, on average, 60 days shorter than approvals from the European Medicines Agency (N Engl J Med. 2017; 376:1386-1387). This is consistent with results from a previous study by the same author group that looked at approvals from 2001 to 2010. One reason for the increase in speed is that the FDA has several expedited development and approval pathways, and approximately three-quarters of the drugs approved in 2016 qualified for one or more of these pathways. In addition, 95% of all new drug approvals are now approved on the first cycle of review. Increased review speed has been associated with problematic safety outcomes, however. One study published in JAMA found an increase in post-approval safety events from 2001 to 2010, with higher events noted among accelerated approvals and near-deadline decisions (JAMA. 2017;317:1854-1863).